Document Detail

Predose infant nevirapine concentration with the two-dose intrapartum neonatal nevirapine regimen: association with timing of maternal intrapartum nevirapine dose.
MedLine Citation:
PMID:  12794547     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: To evaluate cord blood and predose nevirapine concentrations in infants exposed to the two-dose intrapartum neonatal nevirapine regimen. METHODS: The authors obtained plasma samples for nevirapine assay from cord blood and just prior to the 48-hours to 72-hours after birth neonatal nevirapine dose from a subset of infants participating in PACTG 316, a randomized, placebo-controlled trial of the two-dose intrapartum neonatal nevirapine regimen added to standard antiretroviral therapy. RESULTS: Nevirapine concentrations were measured in 109 cord blood samples and 149 predose samples. Cord blood nevirapine concentrations were below the target concentration of 100 ng/mL (10-times the in vitro IC(50) of nevirapine against wild-type HIV) in eight (7%) of 109 infants (95% confidence interval [CI], 3%-14%); the concentrations in six of these infants were below the assay limit of quantitation. Predose infant nevirapine concentrations were below 100 ng/mL in 23 (15%) of 149 infants (95% CI, 10%-22%); the concentrations in 13 of these infants were below the assay limit of quantitation. Lower predose nevirapine concentrations were associated with lower cord blood concentrations and a shorter interval between maternal dosing and delivery. All but one of the infants with predose nevirapine concentrations below the assay limit of quantitation were born less than 2 hours after maternal dosing. CONCLUSION: Infants born less than 2 hours after maternal nevirapine dosing during labor should receive a dose of nevirapine immediately after birth in addition to the standard infant dose at 48 to 72 hours.
Mark Mirochnick; Alejandro Dorenbaum; Suzette Blanchard; Coleen K Cunningham; Richard D Gelber; Lynne Mofenson; Mary Culnane; John L Sullivan
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, U.S. Gov't, P.H.S.    
Journal Detail:
Title:  Journal of acquired immune deficiency syndromes (1999)     Volume:  33     ISSN:  1525-4135     ISO Abbreviation:  J. Acquir. Immune Defic. Syndr.     Publication Date:  2003 Jun 
Date Detail:
Created Date:  2003-06-09     Completed Date:  2003-08-29     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  100892005     Medline TA:  J Acquir Immune Defic Syndr     Country:  United States    
Other Details:
Languages:  eng     Pagination:  153-6     Citation Subset:  IM; X    
Boston University School of Medicine, Boston Medical Center, 91 Concord Street, 6th Floor, Boston, MA 02118, USA.
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MeSH Terms
Anti-HIV Agents / administration & dosage,  pharmacokinetics*
Double-Blind Method
Fetal Blood / metabolism
HIV Infections / blood,  drug therapy*,  metabolism
Infant, Newborn
Nevirapine / administration & dosage,  pharmacokinetics*
Pregnancy Complications, Infectious / blood,  drug therapy*,  metabolism
United States
Reg. No./Substance:
0/Anti-HIV Agents; 129618-40-2/Nevirapine

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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